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Use of TRACLEER® requires attention to two significant concerns: 1) potential for serious
liver injury, and 2) potential damage to a fetus.
WARNING: POTENTIAL LIVER INJURY
TRACLEER® causes at least 3-fold (upper limit of normal; ULN) elevation of liver aminotransferases (ALT and AST) in about 11% of patients, accompanied by elevated bilirubin in a small number of cases. Because these changes are a marker for potential serious liver injury, serum aminotransferase levels must be measured prior to initiation of treatment and then monthly (see WARNINGS: Potential Liver Injury and DOSAGE AND ADMINISTRATION). To date, in a setting of close monitoring, elevations have been reversible, within a few days to 9 weeks, either spontaneously or after dose reduction or discontinuation, and without sequelae. Elevations in aminotransferases require close attention (see DOSAGE AND ADMINISTRATION). TRACLEER® should generally be avoided in patients with elevated aminotransferases (> 3 × ULN) at baseline because monitoring liver injury may be more difficult. If liver aminotransferase elevations are accompanied by clinical symptoms of liver injury (such as nausea, vomiting, fever, abdominal pain, jaundice, or unusual lethargy or fatigue) or increases in bilirubin >/= 2 × ULN, treatment should be stopped. There is no experience with the re-introduction of TRACLEER® in these circumstances.
CONTRAINDICATION: Pregnancy
TRACLEER® (bosentan) is very likely to produce major birth defects if used by pregnant women, as this effect has been seen consistently when it is administered to animals (see CONTRAINDICATIONS).
Therefore, pregnancy must be excluded before the start of treatment with TRACLEER® and prevented thereafter by the use of a reliable method of contraception. Hormonal contraceptives, including oral, injectable, transdermal, and implantable contraceptives should not be used as the sole means of contraception because these may not be effective in patients receiving TRACLEER® (see recautions: Drug Interactions).
Therefore, effective contraception through additional forms of contraception must be practiced. Monthly pregnancy tests should be obtained.
Because of potential liver injury and in an effort to make the chance of fetal exposure to TRACLEER® (bosentan) as small as possible, TRACLEER® may be prescribed only through the TRACLEER® Access Program by calling 1 866 228 3546. Adverse events can also be reported directly via this number.
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